Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension

Completed · Phase 3 · Has a placebo group

Conditions studied: Glaucoma, Open-Angle, Ocular Hypertension

In brief

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).

Key facts

Study ID

NCT02507687

Run by

AbbVie

People needed

240

Starts

2015-08-27

Expected to finish

2023-05-31

Last updated by the study team

2024-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of either open-angle glaucoma or ocular hypertension in each eye that require IOP lowering treatment.
• In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
• In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.

You may not qualify if…

• History of previous laser trabeculoplasty
• History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
• Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
• Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.

Where it is running

• Arizona Advanced Eye Research Institute /ID# 234947 — Glendale, Arizona, United States
• Arizona Glaucoma Specialists /ID# 235066 — Phoenix, Arizona, United States
• M&M Eye Institute /ID# 235391 — Prescott, Arizona, United States
• Walman Eye Center /ID# 236054 — Sun City, Arizona, United States
• California Center for Clin Res /ID# 237412 — Arcadia, California, United States
• Orange County Ophthalmology /ID# 235995 — Garden Grove, California, United States
• Speciality Eye Care Medical Group /ID# 236001 — Glendale, California, United States
• Lugene Eye Institute /ID# 237042 — Glendale, California, United States
• Lakeside Vision Center /ID# 234971 — Irvine, California, United States
• California Eye Specialists Medical Group Inc. /ID# 235999 — Pasadena, California, United States
• North Bay Eye Associates Inc. /ID# 235429 — Petaluma, California, United States
• Pacific Eye Associates /ID# 235326 — San Francisco, California, United States
• Wolstan & Goldberg Eye Associates /ID# 235166 — Torrance, California, United States
• Segal Drug Trials Inc. /ID# 235169 — Delray Beach, Florida, United States
• Eye Associates of South West Florida /ID# 235424 — Fort Myers, Florida, United States
• Levenson Eye Associates Inc. /ID# 235021 — Jacksonville, Florida, United States
• University of Florida /ID# 236876 — Jacksonville, Florida, United States
• Ocala Eye PA /ID# 235431 — Ocala, Florida, United States
• Dr. Andrew Gardner Logan, FL /ID# 236946 — Tamarac, Florida, United States
• University of South Florida /ID# 237737 — Tampa, Florida, United States
• Clayton Eye Clinical Research, LLC /ID# 236678 — Morrow, Georgia, United States
• University of Illinois at Chicago Illinois Eye and Ear Infirmary /ID# 234875 — Chicago, Illinois, United States
• Sabates Eye Centers /ID# 234868 — Leawood, Kansas, United States
• Cincinnati Eye Institute- Edgewood /ID# 236714 — Edgewood, Kentucky, United States
• Trinity Research Group /ID# 234598 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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